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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210499
Company: ACCORD HLTHCARE

Products on ANDA 210499

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	AB	No	No
DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210499

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/24/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210499Orig1s000TAltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/29/2024	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
02/29/2024	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
02/29/2024	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 210499

DIMETHYL FUMARATE

CAPSULE, DELAYED RELEASE;ORAL; 120MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210499	ACCORD HLTHCARE
DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210440	ALKEM LABS LTD
DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210402	AMNEAL
DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210385	AUROBINDO PHARMA
DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210305	CIPLA
DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210309	GLENMARK PHARMS LTD
DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210500	HETERO LABS LTD III
DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210226	LUPIN
DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210460	MSN
DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210531	MYLAN
DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210414	PRINSTON INC
DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210436	SOLA PHARMS
DIMETHYL FUMARATE	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210382	TWI PHARMS
TECFIDERA	DIMETHYL FUMARATE	120MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	Yes	AB	204063	BIOGEN INC

CAPSULE, DELAYED RELEASE;ORAL; 240MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210499	ACCORD HLTHCARE
DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210440	ALKEM LABS LTD
DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210402	AMNEAL
DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210385	AUROBINDO PHARMA
DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210305	CIPLA
DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210309	GLENMARK PHARMS LTD
DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210500	HETERO LABS LTD III
DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210226	LUPIN
DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210460	MSN
DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210531	MYLAN
DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210414	PRINSTON INC
DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210436	SOLA PHARMS
DIMETHYL FUMARATE	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210382	TWI PHARMS
TECFIDERA	DIMETHYL FUMARATE	240MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	Yes	AB	204063	BIOGEN INC

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